MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR VOLUME VIEW SENSOR; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number VLVCVT5

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/30/2021

Event Type  malfunction  

Manufacturer Narrative

One manifold was returned for evaluation.The reported event of broken manifold was confirmed.As received, broken male luer was found stuck in the stand-alone stopcock female luer.The rotating nut of the broken connection was returned separated.The male luer of the t-connector (between swabbable luer sites and injectate temperature probe) appeared damaged.Connection for injectate temperature probe was not returned.Further investigation has been assigned.The lot number was not provided thus a device history record was not reviewed.Invasive procedures involve some patient risks.Although serious complications are relatively uncommon, the physician is advised, before deciding to insert or use a catheter, to consider the potential benefits in relation to the possible complications.The techniques for insertion, methods of using s catheter to obtain patient data information, and the occurrence of complications is well described in the literature.Due to the positive pressure the heart and the ventilator places on the lines, blood will be pushed out into the system if a break were to occur.Therefore, a natural flow of gas into the patient body is possible, but unlikely.It is unknown if user or procedural factors contributed to the stated event.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis and any excursions above the control limits are assessed and documented as a part of the monthly review.

Event Description

It was reported that while using this volumeview set, with a (b)(6) patient hospitalized for treatment of an aneurysmal subarachnoid hemorrhage, the thermistor manifold broke on the distal line of a central venous line.The stopcock and thermistor were exchanged to solve the issue.There was no allegation of patient injury reported.

• Brand Name: VOLUME VIEW SENSOR
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal ; DR
• Manufacturer (Section G): EDWARD LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal ; DR
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 11716970
• MDR Text Key: 248843443
• Report Number: 2015691-2021-02612
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 04/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: VLVCVT5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/06/2021
• Initial Date FDA Received: 04/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 54 YR